General MedicationsORALStandard

ESOMEPRAZOLE MAGNESIUM

Standard Dose

EQ 40MG BASE

Max Dose

Refer to approved labeling

Primary Use

Review priority: STANDARD Marketing status: Prescription

Summary

Approval overview ESOMEPRAZOLE MAGNESIUM is listed in Drugs@FDA under application 217427 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient ESOMEPRAZOLE MAGNESIUM Form and strength CAPSULE, DELAYED REL PELLETS;ORAL - EQ 40MG BASE Sponsor GRANULES Submission history Latest submission status date: 2023-10-18 00:00:00.

Structured Monograph

Clinical summary

Approval overview ESOMEPRAZOLE MAGNESIUM is listed in Drugs@FDA under application 217427 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient ESOMEPRAZOLE MAGNESIUM Form and strength CAPSULE, DELAYED REL PELLETS;ORAL - EQ 40MG BASE Sponsor GRANULES Submission history Latest submission status date: 2023-10-18 00:00:00. Submission type: ORIG.

Monitoring

• Marketing status: Prescription
• Review priority: STANDARD

Interaction Notes

No interaction notes stored yet.